Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, e...

FDA Recall #Z-1005-2015 — Class II — December 16, 2014

Recall #Z-1005-2015 Date: December 16, 2014 Classification: Class II Status: Terminated

Product Description

Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Reason for Recall

the Instructions for Use (IFU) were inadvertently removed from the kit.

Recalling Firm

Arrow International Inc — Reading, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

420

Distribution

In the state of KY

Code Information

Multi-Lumen PI CVC Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015 PSI Kit: 8.5 FR X 4-1/8 (10 CM), product code ASK-09803-OSU2 , lot #23F14C1014, exp. 31-Aug-2015:

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

Back to All Device Recalls

Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, e...